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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT ZERO-P IMPLANT 7MM HEIGHT ZERO-P IMPLANTS

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SYNTHES MONUMENT ZERO-P IMPLANT 7MM HEIGHT ZERO-P IMPLANTS Back to Search Results
Catalog Number 04.617.137S
Event Date 04/10/2009
Event Type  Malfunction  
Event Description

Surgeon had placed a zero-p implant along with cervical spine locking screws and as the surgeon was preparing to close after placement, the construct appeared to back off anteriorly. Surgeon removed the construct and placed an acf spacer to complete the procedure. This is 1 report of 3 on the same incident.

 
Manufacturer Narrative

This information was not provided during initial report. Additional information has been requested. Investigation is ongoing, no conclusion can be drawn. Review of manufacturing records for this lot number has been requested.

 
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Brand NameZERO-P IMPLANT 7MM HEIGHT
Type of DeviceZERO-P IMPLANTS
Manufacturer (Section F)
SYNTHES MONUMENT
monument CO 80132
Manufacturer (Section D)
SYNTHES MONUMENT
monument CO 80132
Manufacturer (Section G)
SYNTHES MONUMENT
1101 synthes ave.
monument CO 80132
Manufacturer Contact
jodi temple
1302 wrights lane east
west chester , PA 19380
(800) 620 -7025
Device Event Key1524540
MDR Report Key1431725
Event Key1362548
Report Number1719045-2009-00083
Device Sequence Number1
Product CodeKWP
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/10/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/05/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.617.137S
Device LOT Number1837779
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received04/10/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/10/2008
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 05/05/2009 Patient Sequence Number: 1
Treatment
SCREWS
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